BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3001818 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03630
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 20, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: EXTENSION: PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: EXTENSION: PRODUCT ID 3387S-40, LOT# V690087, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 3387S-40, LOT# V855467, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: SHOULD ONLY BE CHECKED ¿SERIOUS INJURY.¿ THE INITIAL REPORT INCORRECTLY CHECKED ¿OTHER¿ AND INCLUDED THE EVENT TYPE OTHER TEXT AS ¿SUICIDE IDEATION.¿

    Description of Event or Problem · 1

    THIS WAS A BILATERAL SYSTEM. REFERENCE MFR 3004209178-2013-03632.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SUICIDE IDEATION. THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2013 FOR INPATIENT TREATMENT. THE PATIENT WAS REPORTED TO HAVE "UNDERWENT A FULL PSYCHIATRIC EVALUATION AND MEDICATION ADJUSTMENT." THE PATIENT WAS DISCHARGED ON (B)(6) 2013 WITH "RESOLUTION OF SUICIDE IDEATION." THE PATIENT HAD PREVIOUSLY BEEN ADMITTED AND DISCHARGED FOR SUICIDE IDEATION AS REPORTED IN MFR REPORT # 3004209178-2012-07778 AND MFR REPORT # 3004209178-2012-07779. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105552 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O